Journal of Civil Rights and Economic Development Journal of Civil Rights and Economic Development

Volume 22 Issue 1 Volume 22, Summer 2007, Issue 1 Article 1

Merck and the Vioxx Debacle: Deadly Loyalty Merck and the Vioxx Debacle: Deadly Loyalty

David R. Culp

Isobel Berry

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ARTICLES

MERCK AND THE VIOXX DEBACLE:DEADLY LOYALTY

BY DAVID R. CULP, LA SALLE UNIVERSITY*;

AND ISOBEL BERRY, DESALES UNIVERSITY**

ABSTRACT

This paper discusses the Vioxx tragedy, analyzes the casestried to verdict, and sets out the arguments both for andagainst Merck's actions. It asks whether Merck actedunethically or whether Merck is the victim of overzealousattorneys and runaway juries. The article asks how ten

* David R. Culp, Assistant Professor, La Salle University. Adjunct, DeSales University.

Adjunct, Rutgers State University School of Law. Co-President and Executive Secretary,Ethics Section of the Academy of Legal Studies in Business. President, NortheastAcademy of Legal Studies in Business. Member, Berry and Culp, P.C.** Isobel Berry, Adjunct, DeSales University. Co-President and Executive Secretary,

Ethics Section of the Academy of Legal Studies in Business. Vice-President, NortheastAcademy of Legal Studies in Business. President, Berry and Culp, P.C.

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Merck employees from three different MBA classes canunequivocally and with righteous indignation argue thatMerck acted ethically. The authors ask how employees learnto be so "loyal"? Is that deadly loyalty a product of oureducational system, from kindergarten through MBAprograms, and is the mantra that the purpose of business isto "maximize profits and create shareholder wealth" also aproduct of an educational system that has minimized theinsidious evil and immorality of that doctrine?

INTRODUCTION

As law suits mount against Merck for its marketing of itsblockbuster drug, Vioxx, employees of Merck in three differentMBA classes at two different universities taught by the authorsof this article have unabashedly supported Merck's actions asbeing ethical. Angry at the suggestion that Merck hid thedangers of Vioxx and pulled the drug long after they suspectedthe drug caused an increased risk of serious cardiovascularevents, including heart attacks, stroke, and death, their loyaltyto Merck remains resolute. Is such loyalty deserved, or is there adisconnect with the facts, and if so, why?

In September 2004, Merck voluntarily pulled its blockbusterdrug, Vioxx, from the market after an internal study showed thatlong-term use of Vioxx-eighteen-months or longer-createdtwice the risk of heart attacks and stroke as other drugs used tocombat the pain of osteoarthritis and acute pain in adults.1 UntilMerck removed Vioxx from the marketplace, the drug hadgarnered huge profits for a company that had not had ablockbuster drug for several years. 2 In addition, during the 1999-01 period, Merck had lost its patent protection on five of its best-selling drugs: Vasotec, Pepcid, Mevacor, Priloxed, and Prinivil. 3

1 Merck Pulls Vioxx Across the Globe, (Sept. 20, 2004) available athttp://www.msnbc.msn.com/id/6139592 (noting Vioxx was "pulled off market after studyconfirmed" it heightened risks of heart attack and stroke).

2 Chris Mondics, Two Vioxx Critics Allege Pressure, PHILADELPHIA INQUIRER, Nov. 19,2004, at Al, A22 (stating "Vioxx generated sales of $2.5 billion a year, making it ablockbuster product for a company that in recent years has had difficulty developing newmedications, a problem faced by much of the pharmaceutical industry.").

3 John Simons, Will Merck Survive Vioxx? Looming Lawsuits, Angry Investors,Declining Profits: The Vioxx Debacle is Just the Late Giant., FORTUNE (Nov. 1, 2004),available at http://money.cnn.comlmagazines/fortune/fortune-archive/2004/1 1/01/

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And two of its celebrated cholesterol drugs, Zocor and Prayachol,were to lose their twenty-year patent protection andmarketability by early 2007 when lower-priced generic imitationscame on the market. 4 From 1999-04, Vioxx picked up some of theslack, generating sales of $2.5 billion a year, making it the bestselling drug in the company's history.5

Merck and Vioxx have had a stormy relationship since theFood and Drug Administration's ("FDA") May 1999 approval ofVioxx as reports slowly filtered to the media that long before itsremoval of Vioxx from the marketplace, Merck knew that Vioxxwas a dangerous drug and they nevertheless marketed itaggressively to doctors and an unsuspecting public. 6

Merck is a company that traditionally has had high marks forits ethical practices and social conscience. In its mission/valuesstatement, the company stresses that its "business is preservingand improving human life." 7 Merck's Mission Statementcontinues, "[w]e value, above all, the ability to serve everyonewho can benefit from the appropriate use of our products andservices."8 Throughout its history, Merck has often lived up to itsstated mission. In the 1930's after streptomycin was developedby a Merck scientist, Merck gave up its patent protection since itbelieved the drug was too important a medical breakthrough tokeep to itself.9 Other companies were allowed to producestreptomycin, and Merck lost potential profits. Since the 1980's,when Merck found a cure for "river blindness" caused by aparasitic worm, the company has given away, free of charge, overforty-million pills a year to African nations to treat and cure this

8189593/index.htm (explaining Merck was soon to lose patent protection on some of itsmajor drugs, sales of which represented over five billion dollars annually).

4 Alex Berenson, Big Drug Makers See Sales Erode with Their Image, N.Y. TIMES,Nov. 14, 2005, at Al (highlighting that several drug companies would lose patentprotection by 2007, including Merck).

5 See Mondics, supra note 2 at A22 (noting Vioxx's tremendous sales figures).6 Robert Cohen, Report: Merck Misled Doctors, STAR-LEDGER, May 6, 2005, at 1

(describing House Committee on Government Reform's findings).7 Merck Corporate Philosophy-Mission Statement, http://www.merck.comlaboutl

mission.html (last visited Nov. 13, 2006) (listing Merck's mission and values).8 Id.9 Robert B. Zoellick, President and Chief Executive Officer of the Center for Strategic

and Int'l Studies (CSIS), Keynote Address before the Business-Humanitarian Forum inGeneva, Switzerland: Strategic Philanthropy for Business, Jan. 27, 1999 (describingMerck's history of philanthropy and how it gave streptomycin to Japan to curetuberculosis without earning anything in exchange).

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disease.10 And in 2004 Merck offered to give medicines for free tolow-income Medicare beneficiaries." About 4.2 million seniorcitizens, with very low incomes, are eligible for a $600 annualallowance toward drug costs on government-endorsed Medicarediscount cards. Merck said it would provide its medicines free tothose low-income beneficiaries who have exhausted the $600Medicare subsidy.12

But today, Merck stands awash in lawsuits by those who havetaken Vioxx and suffered heart attacks or strokes. As of April2006, Merck faced over 9,600 cases nationwide.13 That numberdid not include the cases brought by Great Britain residents whohave taken Vioxx and suffered heart attacks or strokes. ByDecember 2006, the number of law suits filed against Merck inthe United States had risen to over 27,000, with an additional265 potential class-action suits. 14 Another 14,000 plaintiffs haveentered into stipulations with Merck suspending the time limitfor filing, and a Canadian judge has approved a class-actionlawsuit for residents of Quebec.15 From 1999-04, over eighty-million people worldwide took Vioxx to treat pain. 16 DavidGraham, a scientist with the FDA, estimates that in just theUnited States, Vioxx may have caused 140,000 heart attacks orstrokes and 55,000 deaths.17

10 Merck Expands Its Commitment to Eliminate River Blindness, available athttp://www.merck.comlabout/featurestory/05192004_mectizan.html (last visited Nov. 13,2006) (noting Merck donated Mectizan to many African and Latin American nations inorder to help cure river blindness).

11 Grace-Marie Turner & Joseph R. Antos, Fixing the New Medicare Law # 3: How toBuild on the Drug Discount Card, available at http://www.heritage.org/Research/HealthCare/bg1752.cfm (Apr. 26, 2004) (describing Merck's philanthropy regarding low-income Medicare recipients).

12 U.S. Dep't of Health and Human Services, $600 Credit and Discounts Combine toGive Low-Income Medicare Beneficiaries Significant Discounts on Prescription Drugs,http://www.cms.hhs.gov/apps/medialpress/release.asp?Counter=1056 (last visited Nov. 13,2006) (listing Merck as one of many medication donors to people with low-incomes).

13 Theresa Agovino, Merck Loses Appeal; Faces Prospect of Nationwide Class-ActionVioxx Lawsuit, (Mar. 31, 2006), available at http://legalsoapbox.freeadvice.com/n15868_Merck-losesappeal;_faces.prospect of nationwideclassactionVioxxlawsuit.htm (lastvisited Nov. 13, 2006) (noting Merck "faces over 9,600 Vioxx-related lawsuits.").

14 Jury Rules in Merck's Favor in Alabama Vioxx Trial, ASSOCIATED PRESS,(December 15, 2006), available at http://www.foxnews.com/story/0,2933,236782,00.html.

15 Janet McConnaughey, Jury Clears Merck in 11th Vioxx Trial; Drug Firm Has Won3of4 Federal Cases, WASH. POST, Nov. 16, 2006, at D3.

16 W. John Thomas, The Vioxx Story: Would It Have Ended Differently in theEuropean Union?, 32 AM. J.L. & MED. 365, 365-66 (2006) (stating more than 105 millionprescriptions were filled for Vioxx between May 20, 1999 and August 2004).

17 Marc Kaufman, Merck CEO Resigns as Drug Probe Continues, WASH. POST, May 6,2005, at Al (describing FDA officers' and others' estimations).

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Merck and its employees argue emphatically that Merck hasbehaved responsibly and ethically. Company representativesclaim that as soon as there was credible scientific evidence ofVioxx's negative health risks in those who had taken the drug foreighteen-months or longer, they pulled the drug.iS They did notwait for the FDA to decide whether to pull the drug, they did sothemselves. Merck employees are incensed at the suggestionthey acted unethically and to maximize profits, withoutconsideration of the health of its customers. 19

I. THE LITIGATION-PICKING THE WINNING HAND

Of the more than 27,000 cases in the pipeline, only 12 havereached a verdict, and most of these are on appeal. Merck hasreceived a jury verdict in eight cases, and plaintiffs have wonfour. Merck has appealed the four losses and vows that it will tryevery case already in the legal system. 20 A ninth case in whichMerck won a jury verdict, the trial court judge has overturned,and the case will be retried. With only 12 decisions out of over27,000 cases, no clear pattern has emerged from the litigation,and experts say it may be years before a pattern is set. It hasbeen estimated that Merck's potential liability could reach $30-50 billion.21 That figure does not include Merck's legal costs to

18 Major Victory for Merck in N.J. Vioxx Trial, (Nov. 3, 2005), available athttp://www.msnbc.msn.com/idi9910674 (last visited Nov. 13, 2006) (providing MerckSenior Vice-President's and General Counsel, Kenneth C. Frazier's opinion that Merckacted responsibly from start to finish with Vioxx).

19 Simons, supra note 3, at 90. Ray Gilmartin, Merck's chairman and CEO respondedthat when he got the bad news about Vioxx from research chief, Peter Kim, "myreaction ... was that we were going to make a decision about Vioxx totally in the interestof patient safety."

20 See Thomas Ginsberg, Merck Defeat in Vioxx Verdict: The Drugmaker Hid Risksfrom the FDA, Jury Ruled, PHILADELPHIA INQUIRER, Apr. 12, 2006, at A01. After thesecond Merck loss on April 11, 2006, in Atlantic City, New Jersey in the McDarby v.Merck case, Kenneth Frazier, Merck's General Counsel, vowed to fight each case, and hisco-counsel, Chuck Harell, has echoed, "[w]e're in this for the long haul .. " Id. ThomasGinsberg, 3rd Vioxx Trial Ends in Hung Jury, PHILADELPHIA INQUIRER, Dec. 13, 2005, atE01 [hereinafter 3rd Vioxx Trial Ends in Hung Jury]. After a hung jury decision inHouston, Texas in December 2005, Frazier had proffered: "The Vioxx litigation will go onfor years. We have the resources and the resolve to address these cases, one by one, in areasonable and responsible manner." Id.

21 Barnaby J. Feder, Federal Panel Consolidates Vioxx Suits, N.Y. TIMES, Feb. 17,2005, at Cl (noting that analysts estimate Merck could face as much as $30 billion dollarsin liabilities stemming from federal and state cases).

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defend the Vioxx litigation. By November 2006, Merck's legalcosts were "sizable: $610 million so far."22

In August 2005, after more than a month of testimony fromscientific experts, a Texas state jury awarded $24.4 million incompensatory damages and $229 million in punitive damages toCarol Ernst, whose husband died in his sleep in 2001 after takingVioxx for about eight months. 23 Under Texas's limitations onpunitive damage awards, the verdict will be lowered to $26.1million. Jurors interviewed following the trial stated that thetestimony and documents presented by plaintiffs counsel, MarkLanier, had demonstrated to them that Merck had long beenaware of Vioxx's potential heart risks and hid this informationfrom patients. 24 In a statement issued after the verdict, Merck'sgeneral counsel, Kenneth Frazier, said that the "verdict in Texaswas a disappointment to all of us at Merck because we know weacted responsibly . . . . We believe we have meritorious defenses,and we intend to vigorously defend individual Vioxx cases one byone:"25

On November 3, 2005, in Atlantic County, New Jersey,with Judge Carol Higbee presiding, Merck won its first juryverdict, a nine-member jury determining that Vioxx did not causeMike Humeston's mild heart attack and that the company didnot .hide risk information. 26 Mike Humeston, sixty-years-of-age,an Idaho postal worker, claimed that Vioxx caused his heartattack in 2001, after less than two months of intermittent use ofVioxx. In an eight to one vote, the jurors found that Merckscientists in 2001 did not believe Vioxx increased the risks ofheart attack and stroke and, therefore, were not obligated towarn physicians, including the doctor who had prescribed Vioxx

22 Avery Johnson & Heather Won Tesoriero, Merck Adds Another Win In VioxxTrials, WALL ST. J., Nov. 16, 2006, at B1.

23 See Alex Berenson, For Merck, the Vioxx Paper Trail Won't Go Away, N.Y. TIMES,Aug. 21, 2005, at 1 [hereinafter For Merck, the Vioxx Paper Trail Won't Go Away](reporting "Texas jury found Merck liable for the death of Robert C. Ernst, who died inMay 2001 after taking Vioxx .... ").

24 See id. (explaining "[t]o the jurors, the evidence added up to a mass of damagingbad facts that overwhelmed the company's defense.").

25 Id.26 See Thomas Ginsberg, Vioxx Victory Key for Merck Jurors Said the Drug Did Not

Cause a Heart Attack. Merck Victory in Trial on Vioxx - 6,400 to go, PHILADELPHIAINQUIRER, Nov. 4, 2005, at A01 [hereinafter Vioxx Victory Key for Merck] (calling case"key victory").

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to Humeston. 27 Voting nine to zero, the jury also rejectedHumeston's consumer fraud claim that Merck had engaged in"unconscionable commercial practices" in marketing Vioxx, andfinding that Merck did not "intentionally suppress, conceal oromit material information" about the potential for cardiovascularproblems. 28 Although the jurors were not required to vote on theissue of "causation," several jurors said they did not believe thatVioxx caused Humeston's heart attack. One juror noted that he"only took it for two months, and he was taking a lot of otherstuff," and a second juror stated that "Humeston had way toomany other risk factors to blame it on Vioxx." 29

The Merck victory was short-lived. During the trial, Merck'sattorneys used Humeston's medical records to demonstrate to thejury that he took Vioxx intermittently over the course of twomonths, while clinical trials had proved a higher risk of heartattack existed only after eighteen-months of daily use.30 Merck'sdefense at trial that clinical studies proved Vioxx created anincreased cardiovascular risk only after eighteen months oftaking Vioxx became the centerpiece for plaintiffs post-trialmotions asking the verdict to be set aside and for a new trial. OnAugust 17, 2006, Judge Higbee granted plaintiffs post-trialmotions. Judge Higbee vacated the jury verdict and ordered anew trial after Humeston's lawyers presented evidence thatduring the trial Merck had withheld evidence whichdemonstrated that the company knew Vioxx posed an increasedrisk of heart attacks even when taken for less than 18 months. 3 1

On February 17, 2006, Merck won a retrial of a Vioxx suit in aNew Orleans federal district court. 32 The first trial had ended ina hung jury, after the jury was unable to reach consensus on

27 See id. Humeston's knee pain resulted from a prior shrapnel wound.28 See id. (noting jury's rejection of Humeston's consumer-fraud claim).29 Id.30 See id. Humeston's medical records revealed he ingested fifty-four pills

intermittently for two months, doubling his dose at times when he felt pain.31 Joshua Pantesco, New Jersey Judge Vacates Merck Vioxx Trial Win, PAPER CHASE

NEWSBURST (Aug. 17, 2006), available at http://jurist.law.pitt.edu/paperchase/2006/08/new-jersey-judge-vacates-merck-vioxx.php.

32 See Merck Buoyed by Vioxx Trial Win, MARKETWATCH (Feb. 21, 2006), available athttp://www.marketwatch.com/news/story/merck-shares-gain-following-vioxx/story.aspx?guid=%7B357A3A2F-3767-4D2E-A90C-F9A74EF9DC28%7D%09%09%09%09%09%09&(last visited Jan. 9, 2007) (explaining this as Merck's third liability case relating to Vioxxand highlighting that Merck had been found liable in a Texas case and not liable in aprevious New Jersey case).

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Merck's liability to a plaintiff, Richard Irvin, a fifty-three-year-old Florida resident, who died from a heart attack in 2001 aftertaking Vioxx for less than a month.33 The second jury reached averdict, finding that Vioxx was not the cause of the plaintiffsheart attack and death. 34 Merck's lawyers had argued at trialthat Irvin's age, gender, and diet all put him at risk for a heartattack. Irvin's widow, a daughter, and a son all testified thatIrvin's health had been excellent up to his heart attack.35 DistrictCourt Judge Eldon Fallon had ruled shortly before trial that twoof the plaintiffs experts-a cardiologist and a pathologist-couldnot testify that Vioxx was the cause of Irvin's heart attackbecause they were experts in their fields but not about Vioxx. 36

On April 5, 2006, in a consolidated case in Atlantic City, NewJersey, Merck lost to plaintiff John McDarby and won a defenseverdict against the second plaintiff, Thomas Cona. 37 TheMcDarby case was Merck's second loss. In the first phase of afive-week trial, the jury concluded that the company concealedthe dangers of Vioxx from McDarby, seventy-seven, and Cona,sixty, and their doctors, and failed to warn them about the drug'sdangers. 38 The jury awarded John McDarby $3 million and hiswife $1.5 million in compensatory damages after concludingVioxx caused his heart attack in 2004 after four years of use. 39

The heart attack has left McDarby extremely weak and frail.40

33 See id. (explaining this was retrial, because previous trial had ended in hung jury).34 See id. (announcing "federal jury in New Orleans rejected a claim that short-term

use of Vioxx played a role in the 2001 death of a 53-year-old Florida man.").35 Jury Sides With Merck in Vioxx Trial, USA TODAY, (Feb. 17, 2006), at

http://www.usatoday.com/money/industries/health/drugs/200602-17-merck-vioxx-case-x.htm (stating Irvin's daughter, son and wife all testified that Irvin had been inexcellent health prior to his heart attack).

36 See id. (noting that the most problematic aspect of the case came when JudgeEldon Fallon would not permit testimony as to whether Vioxx caused Irvin's heart attackbecause plaintiffs experts were experts in medicine, but not about Vioxx).

37 Thomas Ginsberg, Ex-Merck CEO Takes the Stand in Penalty Phase of Vioxx Case,PHILADELPHIA INQUIRER, Apr. 7, 2006, at CI [hereinafter Ex-Merck-CEO Takes theStand] (explaining jury awarded just one of plaintiffs, McDarby of Park Ridge, N.J., $3million and his wife $1.5 million, while rejecting other plaintiffs claim, Thomas Cona,sixty, of Cherry Hill).

38 Id. (stating "first phase, the jury of six women and two men concluded the companyconcealed the dangers of Vioxx to two plaintiffs and their doctors, and failed to warn themabout the drug's dangers.").

39 Id. (highlighting the jury's verdict in favor of McDarby).40 See Thomas Ginsberg, Merck Defeat in Vioxx Verdict: The Drugmaker Hid Risks

from the FDA, Jury Ruled, PHILADELPHIA INQUIRER, Apr. 12, 2006, at A01 [hereinafterMerck Defeat in Vioxx Verdict] (quoting McDarby's wife's statements regarding herhusband's condition).

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The McDarby case was tried with a second case, and in thesecond case, the jury rendered a defense verdict for Merck, on thebasis that Cona had not taken Vioxx as long as he claimed(twenty-five months) and did not prove the drug caused his heartattack.41

In the second phase of jury deliberations, the jury awardedpunitive damages to McDarby in the amount of $9 million.42 Towin punitive damages, McDarby convinced the jury "by clear andconvincing evidence" that Merck "knowingly withheld ormisrepresented" information about Vioxx. 43 The jury was alsogiven instructions by the presiding judge, Superior Court JudgeCarol Higbee, to determine whether Merck had acted with"willful and wanton" disregard for others.44 After the verdict,Kenneth Frazier, Merck's general counsel, asserted that Merckwould appeal what he considered to be mistaken verdicts in bothphases of the trial.45 Of the cases nationwide, about 4,200 are inthe New Jersey Superior Court, and all are assigned to AtlanticCounty Judge Higbee.46

On April 21, 2006, Merck lost its third case when a state courtjury in South Texas awarded $32 million in damages to thefamily of Leonel Garza, a seventy-one-year-old retiree, who diedof a heart attack in 2001 after briefly taking Vioxx.47 Mr. Garza'sfamily claimed that he had taken Vioxx twenty-five days beforehis heart attack. Mr. Garza had a history of heart disease. Hehad a heart attack in 1981, had quadruple bypass in 1985, andwas a smoker who was overweight and had high blood pressure.The family's attorney, Joe Escobedo, argued to the jury thatVioxx was especially dangerous to Mr. Garza because of theseother risk factors and, thus, it should not have been prescribed to

41 See Ex-Merck-CEO Takes the Stand, supra note 37 (stating jury "rejected the claimby... Thomas Cona, sixty, of Cherry Hill, that Vioxx caused his 2004 heart attack afterhe could not prove he took the drug as long as claimed").

42 See Merck Defeat in Vioxx Verdict, supra note 40 (explaining jury awarded$9,000,000 in punitive damages, bringing total award to $13,500,000).

43 Id.44 See id. (noting jurors were asked to decide whether Merck acted with "willful and

wanton" disregard for others).45 See id. (providing Frazier believed trial "riddled with improper rulings from

Higbee").46 Id. (highlighting that Merck's headquarters are located in Whitehouse Station,

N.J.).47 Alex Berenson, Merck Loses Vioxx Suit in Texas, N.Y. TIMES, Apr. 22, 2006, at C1

[hereinafter Merck Loses Vioxx Suit in Texas].

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him.48 Lawyers for Merck denounced the verdict and said thatJudge Alex Gabert should have dismissed the case before itreached a jury because there "really isn't any good science toindicate that Vioxx can cause a heart attack in less than 30days."49 The case is particularly significant in that the juryrejected Merck's argument that Vioxx can only causecardiovascular problems after long-term use. 50 Merck attorneyRichard Josephson said they expected the verdict would beoverturned on appeal and that juries in South Texas have ahistory of returning large verdicts for local plaintiffs againstcompanies with headquarters outside the state.51

On July 13, 2006, Merck won its third Vioxx case when a NewJersey state court jury ruled that Vioxx was not a cause of the2004 heart attack of a sixty-eight-year-old woman, ElaineDoherty. 52 The jury also ruled that although Merck had notwarned her about the drug, the company had warned her doctorof risk factors. The company attributed Ms. Doherty's heartattack to her age, weight, diabetes, cholesterol, blood pressure,and clogged arteries. 53 Ms. Doherty, who is five feet, three inches,once weighed 265 pounds, and is diabetic. Although she had lostnearly one-hundred-pounds, her blood pressure was normal, andher diabetes and cholesterol level were improving, the jury"simply believed that the risk factors were too insurmountable." 54

From August 2006 through January 2007, Merck lost one caseand won five others. On August 2, 2006, a Los Angeles statecourt jury returned a defense verdict in Grossberg v. Merck. In

48 Id. (quoting Mr. Escobedo: "Mr. Garza was the last person in the world that shouldhave been taking Vioxx").

49 Id.; see Christopher Bowe, New Vioxx Study Contradicts Key Merck Defense, FIN.TIMES, May 3, 2006. Despite Merck's assertion, a recent report from McGill University inMontreal, Canada, has confirmed the dangers of short-term Vioxx use. The study lookedat the government health records about 114,000 elderly Quebec people treated with Vioxxand found that about 25% of the Vioxx users who suffered heart attacks had the heartattacks within the first two weeks of taking the drug.

50 See Merck Loses Vioxx Suit in Texas, supra note 47, at C1 (stating Merck's lawyersbelieved case should have been dismissed prior to reaching jury, due to lack of evidencethat Vioxx caused Mr. Garza's heart attack).

51 See id. (highlighting Merck's confidence that verdict would be reversed on appealand noting plaintiff was well-known resident of county where trial was held).

52 Merck Wins Vioxx Case in New Jersey, N.Y. TIMES, July 14, 2006, at C4 (providingjury's findings).

53 See id. (highlighting Ms. Doherty's risk factors).54 Id.

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that case, the jury rejected plaintiffs claims that his 2001 heartattack was caused by his intermittent, sporadic use of Vioxx. 55

On August 17, 2006, a New Orleans federal jury returned averdict for the plaintiff, Gerald Barnett, who at age 58 suffered aserious, but non-fatal heart attack after taking Vioxx for 33months.56 Merck lawyers had argued to the jury that Barnett,who had high blood pressure, a family history of heart disease,and had cardiovascular disease, "was at increased risk for a heartattack regardless of whether he was taking Vioxx." 57 The juryrejected Merck's defense and awarded Barnett $50 milliondollars in compensatory damages after he suffered a heart attackand lost ten years of his life expectancy.S The jury also awardedBarnett $1 million in punitive damages. 59 The jury found thatMerck "knowingly misrepresented or failed to disclose"information to Barnett's doctors about the risks associated withtaking Vioxx and had "acted in wanton, malicious, willful orreckless disregard for the plaintiffs rights."60 On August 30,2006, federal district court judge Eldon Fallon ruled that thecompensatory damages were excessive and ordered a retrial onthe amount of damages to be assessed against Merck. 61

From September 2006 through January 2007, Merck won fourjury verdicts. On September 28, 2006, a federal jury ruled infavor of Merck, the jury finding that Vioxx was not linked toRobert Smith, who at age 52 had a heart attack while shovelingsnow after he had taken Vioxx for knee pain for about fourmonths.62 As in the other cases, Merck argued that plaintiff had

55 Merck Wins First California Vioxx Case, VIOXX (rofecoxib) Information Center(Aug. 2, 2006), http://www.merck.com/newsroomlpress-releases/corporate/2006_0802.html.

56 Helen Steele, Merck Ordered to Pay Damages in Vioxx Case, EARTHTIMES.ORG(Aug. 18, 2006), http://www.earthtimes.org/articles/show/8218.html.

57 Breaking News: Merck Loses Latest Vioxx Trial, WALL ST. J. ONLINE ED. (Aug. 17,2006), http:/fblogs.wsj.comllaw/2006/08/17fbreaking-news-merck-loses-latest-vioxx-trial.

58 See Judge Tosses 'Grossly Excessive' $50 Million Award in Vioxx Case,FOXNEWS.COM (Aug. 30, 2006), [hereinafter$50 Million Award], available athttp://www.foxnews.com/story, 0,2933,211317,00.html.

59 See Breaking News: Merck Loses Latest Vioxx Trial, supra note 57.60 See Merck Ordered to Pay Damages in Vioxx Case, supra note 56.61 Statement of Phil Beck on Today's Ruling Overturning an Excessive VIOXX

Damage Award, VIOXX (rofecoxib) Information Center (Aug. 30, 2006),http://www.merck.com/newsroom/vioxx/pdf/barnettdamages-overturned-statement-phil-beck.pdf.

62 Merck Wins Federal VIOXX Product Liability Case: Smith v. Merck & Co., Inc.,VIOXX (rofecoxib) Information Center (Sept. 26, 2006),http://www.merck.com/newsroom/pressreleases/corporate/2006_0926.html.

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pre-existing risk factors for a heart attack, such as high bloodpressure, high cholesterol, a family history of cardiac problems,coronary heart disease, and he was considered medically obese.63

Merck argued that these increased risk factors, not Vioxx, causedhis heart attack. 64

On November 16, 2006, a New Orleans federal jury exoneratedMerck for the heart attack of Ron Mason, 64, who was seeking$690,000 in lost wages and other damages for a 2003 heartattack after taking Vioxx for 10 1/2 months. 65 In closingarguments, Merck lawyers argued that Vioxx could not havecaused Mason's heart attack because he took the painkiller forless than a year and stopped taking it four days before the heartattack. 66 Merck's defense strategy that Vioxx is dangerous onlyafter a patient ingests the drug continuously for at least 18months is the same argument that Merck has used to defendother cases, including the Humeston case. As set out supra, thetrial court judge in the Humeston case overturned the juryverdict for Merck and ordered a new trial on the basis that Merckhad withheld evidence during the Humeston trial whichdemonstrated the company knew Vioxx posed an increased riskof heart attacks even when taken for less than 18 months.

On December 13, 2006, a New Orleans federal court jury foundin favor of Merck, rejecting Anthony Diedrick's claim that hisheart attack at age forty-seven was caused by taking Vioxx forsix months prior to the heart attack. 67 Merck followed itspatterned defense. Merck lawyers argued that Diedrick was atincreased risk for a heart attack, suffering from high bloodpressure, high cholesterol and diabetes, and Diedrick, therefore,would have suffered a heart attack whether he took Vioxx ornot.68 On December 15, 2006, Merck won again when anAlabama federal court jury found that Vioxx did not cause Gary

63 Id.64 Id.65 See McConnaughey, supra note 15.66 Id.67 Merck Wins Federal VIOXX Product Liability Case, VIOXX (rofecoxib) Information

Center (Dec. 13, 2006), http://www.merck.comlnewsroomlpress-releases/corporate/2006_1213.html.

68 Id.

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Albright's "small heart attack."69 Merck's lawyers argued thatAlbright had hypertension, diabetes, high blood pressure, highcholesterol, and was overweight. 70 After the case, jurors statedthat Albright had too many health problems to blame his heartattack on Vioxx.71

On January 19, 2007, a Los Angeles state trial court judgedeclared mistrials after a jury failed to return verdicts inlawsuits filed by two Vioxx users who claimed that Vioxx was amajor cause of their heart attacks. 72 The cases will be retried.

With 27,000 cases still to be tried, and only 12 having reacheda verdict, with most of those on appeal, it is too early in theprocess, which will take years to unfold, to predict the patternthat may emerge from the Vioxx litigation. Merck's defensestrategy, however, is clear. The plaintiffs are not "perfect"plaintiffs: Many were at increased risk for cardiovascular eventsbecause of pre-existing hypertension, or being overweight, orhaving a family history of cardiac problems. Merck hopes thesefactors will persuade jurors that plaintiffs would have suffered aheart attack or stroke even if they never took Vioxx. Merck'sargument is that plaintiffs cannot meet their burden of proof thatVioxx was the "proximate cause" or a major contributor toplaintiffs cardiovascular problems. Some juries have agreedwith Merck, and others have not. Some juries have agreed withMerck that the company did not fail to warn or give informationabout the dangers of using Vioxx, while others have found notonly that Merck negligently failed to warn consumers of theincreased risks of taking Vioxx, but that Merck "knowinglywithheld or misrepresented" information about Vioxx and hadacted with "willful and wanton" disregard for the rights andhealth of Vioxx users who have suffered a heart attack or stroke,and that these malicious and reckless actions justify punitivedamage awards of several million or more.

69 See Jury Rules in Merck's Favor in Alabama Vioxx Trial, supra note 14 (statingthat Merck attorney Mike Brock told jurors that Albright had only a "small heart attack"that did not cause lasting damage to his lifestyle).

70 Id.71 Id.72 See VIOXX Plaintiffs Failed to Prove Their Cases, VIOXX (rofecoxib) Information

Center (Jan. 18, 2007), http://www.merck.comlnewsroom/press-releases/corporate/20070118.html.

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Although no clear pattern is discernable after twelve cases,there likely may develop a correlation between using Vioxxcontinuously for more than a few months and the seriousness ofthe harm to a plaintiff. In two of the plaintiffs' decisions, in theErnst case, the plaintiff used Vioxx continuously for eightmonths and died from a heart attack, and in the McDarby case,plaintiff took Vioxx for four years and suffered a near-fatal heartattack. In the Merck defense verdicts, in the Humeston caseplaintiff took Vioxx for two months intermittently and suffered amild heart attack; in the Irvin case plaintiff died of a heart attackafter taking Vioxx for less than a month; and in the Cona case,plaintiff said he took Vioxx for twenty-five months beforesuffering a heart attack, although jurors after the verdict saidthey did not believe that Cona had taken the drug for as long ashe had claimed. The Garza case, in which a Texas jury gave aplaintiffs verdict for the death of seventy-one-year old, LeonelGarza, who had taken the drug for less than a month and hadother risk factors, may or may not be an anomaly. Certainly, itshows, as Merck general counsel Kenneth Frazier noted, that the"realities of the world are that jury cases have uncertainoutcomes."73 It also shows that Merck is at risk in the Vioxxcases.

In the McDarby case, the attorney representing plaintiff wasMark Lanier. This was his second win against Merck, and untilthe Garza verdict, he was the only attorney to have won a Vioxxcase. This has raised questions as to whether Lanier is simply asuperior attorney who wins cases that most other attorneyswould lose. Is he such a charismatic and master spin artist thathe subverts the truth and justice? In the cases Lanier has tried,Merck certainly believes the jury has been blind and misguided.Or has Merck been myopic and short-sighted in its handling ofthe Vioxx debacle? The Merck-Vioxx controversy raises issues asto whether Merck acted unethically and callously or whetherMerck is, as many of its employees claim, a victim of overzealouslawyers and their clients as well as of other pharmaceuticalcompanies jealous of Merck's reputation which wish to damagethat reputation to drive Merck's profits down and theirs up.7 4

73 See Merck Loses Vioxx Suit in Texas, supra note 47, at C1.74 In fall 2005 and winter 2006 MBA courses this author taught, there were six Merck

employees who were in the two classes. In the winter 2006 class, one Merck employee

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II. WHAT DID THE COMPANY KNOW AND WHEN DID THEY KNOW

IT?

A. Merck's Defense

Merck has defended the Vioxx cases on two grounds. First,that they acted responsibly by voluntarily withdrawing Vioxxfrom the marketplace in 2004 after the first reliable studyshowed that long-term use of Vioxx increased the risk of seriouscardiovascular events.75 Thus, Merck did not hide credibleinformation of Vioxx's risks from consumers. Second, Merck hasargued that in none of the cases to date has plaintiff met hisburden of proof that Vioxx "caused" his heart attack.76

Merck's has argued that the company had no reliable scientificevidence that Vioxx increased the risk of cardiovascular eventsuntil September 2004 when a clinical trial, designed to see ifVioxx could prevent colon polyps, showed an increased risk ofheart attack and stroke among patients taking Vioxx foreighteen-months as compared to those who took placebos. 77

Merck immediately contacted the FDA on September 27, 2004,and in a meeting with the FDA on September 28, Merck informedthe agency it would voluntarily withdraw Vioxx. 78 Two days later

argued that he thought the Vioxx controversy partially stemmed from otherpharmaceutical companies jealous of Merck's reputation as an ethical company who had ablockbuster drug. All six employees believed that Merck had acted ethically and that thefault for the litigation was greedy plaintiff attorneys and their clients, who were playingthe great American lottery game-the jury system.

75 See Merck Loses Vioxx Suit in Texas, supra note 47, at C1 (noting Merck'swithdrawal of Vioxx after clinical trial revealed an increased risk of heart attack andstroke when compared with placebos); see also Merck Wins Vioxx Case in New Jersey,supra note 52, at C4 (stating that Merck withdrew Vioxx after a trial which showed thatit doubled the risk of heart attack when taken for eighteen months).

76 See Merck Loses Vioxx Suit in Texas, supra note 47, at C1 (pointing to decedent'smedical history prior to his use of Vioxx including quadruple heart bypass and a history ofsmoking and weight problems); see also Merck Wins Vioxx Case in New Jersey, supra note48, at C4 (attributing heart attack not to Vioxx, but rather to other risk factors such as:age, weight, diabetes, cholesterol, blood pressure, and clogged arteries).

77 Press Release, U.S. Food and Drug Administration, FDA Issues Public HealthAdvisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product (Sept. 30, 2004)[hereinafter FDA Issues Public Health Advisory on Vioxx], available athttp://www.fda.gov/bbs/topics/news/2004/NEW0l122.html (explaining nature and resultsof Merck's studies).

78 See id. (stating that Merck chose to voluntarily remove Vioxx from marketfollowing learning of these risks).

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Merck announced its withdrawal. 79 "Merck did the right thing bypromptly reporting these findings to FDA and voluntarilywithdrawing the product from the market," said the Acting FDACommissioner Dr. Lester M. Crawford. 80 He continued,"[a]lthough the risk that an individual patient would have aheart attack or stroke related to Vioxx is very small," the studyshows "that patients taking the drug chronically face twice therisk of a heart attack compared to patients receiving a placebo."8 1

At the McDarby trial, on April 6, 2006, Raymond Gilmartin,Merck's ex-CEO,82 testified on cross-examination by Lanier thathe never knowingly masked safety data.8 3 When asked whyMerck had not turned over to the FDA an October 2000 internalanalysis showing the risk of heart attack by Vioxx users rangedfrom zero to five-fold over other pain relievers, Gilmartintestified that Merck had not been obligated to turn the internalanalysis over to the FDA.84 The October 2000 internal analysisby Merck scientist Deborah Shapiro was titled "preliminary"summary of data. "What we gave" to the FDA, Gilmartintestified, "was the raw data, and they do their own analysis."85

Lanier asked, "[a]re you saying it was important enough forMerck to do this study, but not important enough to send to theFDA?"86 "No, I'm not telling you that at all," Gilmartin replied,stating that Merck's analysis was only preliminary and thuspotentially flawed.8 7 He added, "[w]e submit what we believe isthe appropriate analysis, and I'm confident we submitted the

79 Id. The FDA announced the voluntary withdrawal of Vioxx from the market onSeptember 30, 2004, two days after its meeting with Merck wherein Merck disclosed itsfinding concerning colon polyps.

80 Id. (commending Vioxx for voluntary withdrawal despite FDA's increased scrutinyof that drug).

81 Id.82 See Kaufman, supra note 17, at Al. Gilmartin resigned as CEO on May 5, 2005,

the same day that congressional investigators released a slew of documents detailing howthe company continued to aggressively promote Vioxx after it knew of potentially serioussafety concerns.

83 See Ex-Merck-CEO Takes the Stand, supra note 37, at Cl. Responding to an emailpresented by the Plaintiff in which Merck chief scientist complained of a lack of freedomunder the new CEO, Gilmartin reaffirmed his statement that he never knowinglywithheld data and stated that the scientist "did have freedom." Id.

84 See id. (admitting Merck failed to turn over potentially "damning internalanalysis").

85 Ex-Merck-CEO Takes the Stand, supra note 37, at Cl.86 Id.87 See id. (denying Lanier's accusations).

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data."88 On redirect examination, Gilmartin testified that Merckhad submitted to the FDA a different analysis, dated 2001,containing all the same data, but laid out in a different form.8 9

In addition, Merck has argued that it acted responsibly insubmitting to the FDA in June 2000, the results of a study calledVIGOR,90 which showed a four-time increase in the risk ofserious cardiovascular events compared to naproxen. 91 Merckalso released this information to the media, although they did notdirectly contact physicians prescribing Vioxx.92 Merck hasclaimed that any wide-awake physician would have known of thepublished research on the VIGOR studies. In April 2002, theFDA asked for changes in the labeling of Vioxx to warnphysicians and patients of the risks, and Merck complied withthe FDA request. 93

Those defending Merck have argued that no drug is withoutrisk. They reason that drugs cannot be made perfectly safe, andeven aspirin can have side effects. Thus, a person who takes

88 Id.89 Id.90 See Report of John S. Martin, Jr. to the Special Comm. of the Bd. of Dir. of Merck &

Co., Inc. Concerning the Conduct of Senior Mgmt in the Dev. and Mktg. of Vioxx (Sept. 5,2006), available at http://www.merck.com/newsroom/vioxxlpdfl 005exhibit_4_glossaryof terms.pdf (defining VIGOR as Vioxx Gastrointestinal Outcomes Research andexplaining it as "[d]ouble-blind study by MRL assessing the comparative efficacy andgastrointestinal safety of Vioxx 50 mg and naproxen 1000 mg; found a statisticallysignificant decrease in PUBs among patients on Vioxx and a statistically significantdifference in cardiovascular adverse events favoring naproxen.").

91 See FDA Issues Public Health Advisory on Vioxx, supra note 77 (discussing Merck'sJune 2000 submission of the VIGOR safety study to the FDA and quoting Acting FDACommissioner Dr. Lester M. Crawford: 'qMerck did the right thing by promptly reportingthese findings to FDA and voluntarily withdrawing the product from the market").

92 See, e.g., Claire Bombardier M.D. et al., Comparison of Upper Gastrointestinal

Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis, NEW ENG. J.MED. 1520, 1522-1525 (2000) (assessing rofecoxib's efficacy in first scholarly articledealing with effects of drugs like Vioxx based on information provided by Merckemployees); Eric J. Topol, M.D., Failing the Public Health - Rofecoxib, Merck, and theFDA, NEW ENG. J. MED. 351;17, 1707, 1707 (2004) (criticizing Merck's failure to releasedata on drug until November 23, 2000, when New England Journal of Medicine reporteddata in Bombadier article that later became subject of attack on Merck because data wasfound to be based on incomplete information).

93 See Report of John S. Martin, Jr. to the Special Comm. of the Bd. of Dir. of Merck &Co., Inc. Concerning the Conduct of Senior Mgmt in the Dev. and Mktg. of Vioxx (Sept. 5,2006), available at http://www.merck.com/newsroom/vioxx/pdf/032-appendix -n fda_analysis-ofvioxxcardiovasculardata-and labelissues.pdf. The FDA and Mercknegotiated over revisions to the Vioxx label that were approved on April 12, 2002. Merck'sfinal version incorporated the FDA's proposals, "which included specifying that theserious cardiovascular events in the VIGOR Trial included sudden death .... Merck alsoaccepted the FDA's request to relocate cautionary language concerning the use of Vioxx bypatients with a medical history of ischemic heart disease from the end of thecardiovascular precaution to the beginning." Id.

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drugs must understand that there are side effects and takeresponsibility for his/her decision to take any medication. 94 Inaddition, the risk of a heart attack or stroke from using Vioxx isstill a small risk. 95

B. The Case Against Merck

i. The Vioxx Clinical Trials

Prior to the FDA's approval of Vioxx in May 1999, there wasevidence that Merck had concerns that the drug may causeserious cardiovascular events. 96 Internal Merck documentsshowed that company executives and scientists were worriedabout Vioxx's potential cardiovascular risks as early asNovember 1996-more than two years before selling the drug-but rejected plans to conduct a study evaluating these risks. 97 ANovember 1996 internal memorandum by a Merck officialindicated the company was struggling with a marketingdilemma, as Vioxx had limited market potential unless it couldgain acceptance in the mass market for pain killers and bepreferred to cheap over-the counter-drugs such as aspirin oribuprofen, which cost about five cents a pill versus several dollarsfor Vioxx. 98 The author of the memorandum noted that Merckwas reluctant to conduct a trial to prove Vioxx was gentler on the

94 These comments were made by students in the author's MBA class on BusinessEthics discussing Vioxx during the fall 2005 semester at La Salle University. Althoughthese comments may not have been made by Merck scientists and executives, theynevertheless represent the "maximization of profits" mindset.

95 See FDA Issues Public Health Advisory on Vioxx, supra note 77. Acting FDACommissioner Dr. Lester M. Crawford stated that "[a]lthough the risk that an individualpatient would have a heart attack or stroke related to Vioxx is very small... " patientstaking Vioxx nonetheless were at twice the risk of suffering heart attacks when comparedto patients given placebos. Id.

96 See Alex Berenson, Jury Calls Merck Liable in Death of Man on Vioxx, N.Y. TIMES,Aug. 20, 2005, at Al [hereinafter Jury Calls Merck Liable] (stating that documents andemails from Merck scientists discussed these potential heart risks in 1997).

97 See Berenson, supra note 4, at A17 (citing internal Merck documents).98 See generally Marc Kaufman, New Study Criticizes Painkiller Marketing, WASH.

POST, Jan. 25, 2005, Al [hereinafter New Study Criticizes Painkiller Marketing]. A studypublished in "Archives of Internal Medicine" asserted that the majority of patients whowere persuaded by direct-to-consumer advertising campaigns of prescription arthritisdrugs such as Vioxx would have experienced similar results on older, cheapermedications. The study stated that the aggressive direct-to-consumer advertisingcampaigns launched in 1998 and 1999 lead to the drug's overuse by patients and doctors.Advertising reports indicated that Merck spent $79.2 million on Vioxx ads in 2003,making Vioxx one of the most heavily advertised drugs of all time.

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stomach than older painkillers because in order to clearly showthis difference, the patients using Vioxx could not also takeaspirin, which reduces the risk of heart attacks. This created adilemma because if patients could take only Vioxx but not anyaspirin there was "a substantial chance that significantly higherrates" of cardiovascular problems would occur in this group.99 Ina 1997 e-mail message, Dr. Alise Reicin, a Merck scientist wrote:"The possibility of increased C.V. events is of great concern."1 00

C.V. "is a scientific shorthand for cardiovascular problems" suchas heart attack or stroke.Z0i "I just can't wait to be the one topresent those results to senior management," she continued.1 02

A 1998 Merck clinical trial called "Study 090" involving 978patients showed that serious cardiovascular events, includingheart attack and stroke, occurred almost six times more often inpatients taking Vioxx than in patients taking another arthritisdrug or a placebo.10 3 Merck did not publish the clinical trial. 104

In 1998 medical researchers at the University of Pennsylvaniareported findings that Cox-2 inhibitors, such as Vioxx, mightinterfere with enzymes thought to play key roles in warding offcardiovascular disease. The findings were communicated to thecompanies such as Merck developing Cox-2 inhibitors and werealso published. 105

In May 1999, the FDA approved the use of Vioxx for thereduction of pain and inflammation caused by osteoarthritis, foracute pain in adults, and for the treatment of menstrual pain.106

99 See Anna Wilde Mathews & Barbara Martinez, Warning Signs: Emails SuggestMerck Knew Vioxx's Dangers at Early Stage - As Heart-Risk Evidence Rose, OfficialsPlayed Hardball; Internal Message: 'Dodge!'- Company Says 'Out of Context, WALL ST.J., Nov. 1 2004, at Al. Merck officials acknowledged that unless these patients also tookaspirin more blood clots would occur.

100 For Merck, Paper Trail Won't Go Away, supra note 23, at 1.101 See id. (explaining this term).102 Id.103 See 60 Minutes: Prescription for Trouble (CBS television broadcast Nov. 14, 2004),

available at http://www.cbsnews.comlstories/2004/11/14/60minutes/main655577.shtml(describing results from Dr. Eric Topol's, chief of cardiovascular medicine at ClevelandClinic, statistical analysis on Vioxx).

104 See id. (explaining Merck considered study too small and statistically insignificantto warrant conclusive evidence).

105 Simons, supra note 3 (quoting study's author as saying "[wie immediatelypostulated to the companies developing COX-2 inhibitors, and subsequently reported inprint, that this was something that could lead to heart attacks and strokes").

106 See Sandra Kweder, M.D., Deputy Director of the Office of New Drugs at theCenter for Drug Evaluation and Research ("CDER"), and FDA, Statement Before U.S.Senate, Committee on Finance, (Nov. 18, 2004), available at http://www.fda.gov/olal

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At the time of approval, the FDA reviewer, Dr. Villalba, wrote amemorandum expressing his concern that the data availableseemed to suggest that cardiovascular events are more frequentin patients taking Vioxx rather than a placebo.107

Although Merck scientists and executives, as well as otherscientists, had concerns about the cardiovascular effect of Vioxxprior to its FDA approval, the company failed to conductcardiovascular trials that would directly examine whether therewere increased cardiovascular events associated with takingVioxx. The failure of Merck to conduct cardiovascular trials tomeasure cardiovascular events continued from 1999 until 2004,when Merck pulled the drug from the market. Merck neverperformed a study dedicated to measure cardiovascular effects.Several scientists have claimed that Merck conducted studiesthat would place Vioxx in the best light possible to market thedrug, and not to find out the extent, if any, to which Vioxx causedcardiovascular problems. 108

In June 2000 Merck submitted to the FDA the final data fromVIGOR, which showed a decrease in gastrointestinal problems,but a four-fold higher risk of heart attack compared withnaproxen. 109 Merck had conducted the study to see if Vioxx had alower risk of gastrointestinal ulcers and bleeding than otherdrugs such as ibuprofen and naproxen. Merck reported theresults of the study in the New England Journal of Medicine, butdid not notify physicians of the findings.

Subsequent to reviewing the VIGOR study and results fromother controlled clinical trials, the FDA conferred with itsArthritis Advisory Committee in February of 2001 in reference tothis new safety information.11 Fourteen months later, in April2002, the FDA implemented labeling changes to reflect these

2004/vioxxl 118.html (noting "FDA approved Vioxx in May 1999 for the reduction of signsand symptoms of osteoarthritis, as well as for acute pain in adults and for the treatmentof primary dysmenorrhea.").

107 Eric J. Topol, M.D., Rofecoxib, Merck, and the FDA, NEW ENG. J. MED. 351;27,2875, 2877 (2004) (describing Dr. Villalba's statements at time of Vioxx's approval in May1999).

108 See id. at 2877-78 (discussing previous studies and comments made by somescientists involved).

109 See FDA Issues Public Health Advisory on Vioxx, supra note 77 (noting bothbenefit of decreased gastronomical side effects and increased risk of cardiovascular eventscompared to other drugs).

110 Id.

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new findings.ill The labeling changes required that Merck warnconsumers about the heightened risk of cardiovascular side-effects, namely, "heart attack and stroke."112 Nevertheless, fromthe time that Merck submitted the information to the FDAtwenty-months elapsed before physicians were notified of thedangers of using Vioxx, as shown by the VIGOR study.

Despite the cardiovascular risks, Merck engaged inmisdirection and down-played the results of the VIGOR study.As the FDA and other scientists have noted, the VIGOR studyshowed cardiovascular events increased five-fold from use of thedrug, not four-fold as Merck claimed."l 3 Additionally, Merckcould have chosen to notify prescribing physicians of theirfindings in March 2000, when they received the results of theVIGOR study; yet, they chose not to do so. Merck's argumentthat a wide-awake physician would have read the New EnglandJournal of Medicine belies the reality of a medical practitioner'slife. Doctors do not read every piece of professional literatureany more than attorneys do. Doctors rely on the salesperson togive them accurate information about the drug.114 Moreover, thelegal standard is not whether the FDA was notified or there wasa journal article discussing the VIGOR study, but whether Merckadequately notified treating physicians of Vioxx's risks ofcardiovascular events that Merck either knew or should haveknown about."iD Until forced by the FDA in April 2002 to changeits labeling to reflect the increased risks of cardiovascular events,Merck chose to ignore the health implications shown by the

111 Id.112 See id. (describing types of risks Vioxx labels had to explain).113 See Healthwatckh Thmeline Of V.or-Related Events (CBS television broadcast Apr. 5, 2006),

available at http'/www.cbsnews.co mstoies/2006R04/05/healthmain1476188.shtml. "June 2000: Merckgives FDA results of VIGOR study, which shows Vioxx users suffered five times as many heart attacksas users of the older painkiller naproxen .... Id.

114 See Kevin Freking, Selling Vioxx: Merck Used Code-Named Projects to Boost TheirSales Despite Safety Concerns, SEATTLE TIMES, May 5, 2005, at Nation & World (testifyingbefore House Government Reform Committee about how drugs are marketed to doctors,Dr. Michael Wilkes, vice dean for medical education at University of California-Davis,admitted doctors are busy and look for shortcuts to get information).

115 See Vioxx Victory Key for Merck, supra note 26, at A01. In the Humeston case, thetrial court judge gave the jury the following instruction: "Did Merck fail to provide anadequate warning to prescribing physicians of an association between Vioxx and anincreased risk of serious cardiovascular events that the defendant ether knew or shouldhave known about prior to Mr. Humeston's heart attack?" Id. In an 8-1 vote, theHumeston jury sided with Merck, finding there was no failure to warn since Merck didnot believe in 2001 at the time of Humeston's mild heart attack that Vioxx increased therisk of cardiovascular events.

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VIGOR study. Despite ex-CEO Gilmartin's testimony at trialthat Merck "wanted" to place a warning label on the Vioxxmedicine,116 internal Merck documents show otherwise.iX7

Lanier introduced in the Ernst trial internal Merck documentswhich reveal that Merck resisted the FDA's efforts to addwarnings to Vioxx's label and eventually complied in ways thatthe Ernst jury found obscure. "You had to dig three levels to seeit," one juror stated.118

In addition, Merck downplayed the VIGOR results,hypothesizing that naproxen, like aspirin, benefited the heartand that Vioxx did no harm.119 Merck did not conduct trials totest this hypothesis,120 but that did not stop Merck frommarketing the drug and downplaying the VIGOR study.

In March 2000, when Merck became aware of the VIGORstudy's findings of a significant increase in cardiovascular eventsfor those taking Vioxx over naproxen, Merck scientists expressedconcern. In an e-mail message written in March 2000, Dr.Edward Scolnick, who was then Merck's head of research, statedthat the VIGOR clinical trial had shown that Vioxx increasedheart risks.121 "The CV events were clearly there," he wrote.122

Despite clear warnings, Merck decided against conductingstudies on the heart risks because marketing executives worriedit might hurt Vioxx's sales.123 Internal Merck analyses in 2001

116 See Ex-Merck-CEO Takes the Stand, supra note 37, at C1 (responding toassertions that Merck was influenced by potential lost sales that if new warning labelwere placed on Vioxx).

117 See For Merck, the Vioxx Trail Won't Go Away, supra note 23, at 1. In the Ernsttrial jurors were presented by the plaintiff with a series of e-mails and internal Merckdocuments which indicated that Merck had resisted the F.D.A.'s efforts to add warningsof potential heart risks to the Vioxx label).

118 Id. (describing one version of the drug's labeling).

119 See Rita Rubin, Merck Repeats: We Didn't Know of Vioxx Threat, USA TODAY, Oct.14, 2004 (providing "company credited naproxen for preventing blood clots from formingand causing heart attacks or stroke.").

120 Id. "Animal studies suggested that was the case, said Alise Reicin, vice presidentof clinical research at Merck Research Laboratories. However, Merck wrote in a March2000 press release, there had been no human trials to confirm that naproxen did indeedprotect against heart attacks and strokes." Id.

121 See Alex Berenson, In Training Video, Merck Said Vioxx Did Not Increase Risk ofHeart Attack, N.Y. TIMES, July 21, 2005, at C4 [hereinafter In Training Video, Merck SaidVioxx Did Not Increase Risk of Heart Attack] (indicating evidence was introduced to juryin Robert Ernst's case).

122 Id.123 See For Merck, the Vioxx Paper Trail Won't Go Away, supra note 23 (describing

ways in which sales representatives were trained to dodge questions about Vioxx's heartrisks).

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and 2002 also showed that Merck was worried about lost profitsif warnings or precautions were put on its label.124 During thatperiod, Merck was in private negotiations with the FDA overchanges to its Vioxx label. David Anstice, who, at that time, wasthe president of Merck's Human Health division, projected that astrict warning would reduce sales by at least 50%.125

After the VIGOR study findings in March 2000, a secondinternal Merck analysis performed in October 2000 also showed asignificant increase in cardiovascular events for those takingVioxx. 126 The Merck analysis, plaintiffs attorney Mark Lanierhas argued, was never presented to the FDA nor to the media,and certainly was not given to the physicians prescribingVioxx.127 The analysis was simply buried inside Merck.Gilmartin's response during examination by Lanier at McDarby'strial was that the analysis was "preliminary" and "potentiallyflawed"; the FDA received the raw data and could do their ownanalysis; and Merck was not obligated by FDA rules to domore. 128 The internal analysis, called a meta-analysis, revealedthat patients taking Vioxx were twice as likely to suffer heartattacks as those taking other painkillers.129 Merck's analysisincluded the review of 20,000 study patients from five trials.Although some findings from the study were given to the FDA inJanuary 2001 in preparation for a regulatory meeting, Merck didnot include the portion that measured the rates at which Vioxxusers suffered heart attacks.130

124 See id. (stating that "$229 million punitive damages figure was not picked atrandom, but reffered to a 2001 Merck estimate of additional profit the company mightmake if it could delay an F.D.A. warning on Vioxx's heart risk.").

125 See Thomas Ginsberg, Merck's Former Chief Executive Denies Concealing SafetyData, PHILADELPHIA INQUIRER, Apr. 6, 2006. Gilmartin's response was that the lost profitanalysis "didn't have any influence over the discussion" with the FDA, that "it hadnothing to do with our negotiations" and that Merck "wanted that label." Id.

126 See Peter Loftus, Jury Says Merck Misled FDA, Awards Another $9M to HeartAttack Victim, N.Y. SUN, Apr. 12, 2006, at 12 (discussing case of seventy-seven-year-oldman who had heart attack after taking Vioxx and highlighting this memo's use asevidence at trial).

127 See id. (noting Lanier's statements regarding Merck's failure to release thisinformation).

128 See id. (stating that "Merck argued that the analysis was preliminary and notrequired by the FDA, and said it did submit the underlying clinical data.").

129 See Ed Silverman, Links to Heart Attacks Withheld; Merck Says it Didn't Need toReport its Findings on Vioxx to the FDA, POST-STANDARD, July 5, 2005, at B6(highlighting that Merck conducted "internal analysis... that revealed patients takingthe drug were twice as likely to suffer heart attacks as those on similar painkillers.").

130 See id. (describing Merck's omission of this portion of data).

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Despite clear danger signals in 2000 from VIGOR and meta-analysis studies and a request in 2001 from a group of scientiststhat Merck conduct dedicated cardiovascular trials, Merck didnot do so, 131 preferring instead to conduct trials that would showthe potential benefits of Vioxx. Such trials included the VIGORtrial (dedicated to showing whether Vioxx decreased the risk ofgastrointestinal problems sometimes associated with other painrelievers) and the APPROVe132 and VICTOR133 trials (dedicatedto measuring whether Vioxx prevented the formation of colonpolyps and was helpful in treating patients with a history ofcolon cancer).

Aided by Merck's masking negative trial results and failure toconduct dedicated cardiovascular trials, the FDA approvalprocess failed. The pre-approval trials to determine the safety ofthe drug lasted less than twelve months, even though manypeople taking Vioxx for arthritis would likely take the drug formuch longer periods of time. 134 Swiss Scientist Matthew Eggarand a co-scientist analyzed the results from eighteen randomizedclinical trials and eleven observational studies-many completedbefore 2001-and determined that Vioxx could have, and shouldhave, been pulled from the market long before September2004.135 Egger stated that "[i]f we can do this kind of analysis,

131 See Topol, supra note 107, at 1707 (asserting Dr. Eric Topol, M.D. and hiscolleagues asked Merck to perform dedicated cardiovascular trials specifically designed tocompare the incidence of serious cardiovascular events in patients taking Vioxx ascompared with those taking other pain relievers or placebo).

132 See Vioxx Timeline Key Dates for VIGOR and Long-Term, Placebo-ControlledStudies Implemented to Provide Cardiovascular Safety Data, http://www.merck.comlnewsroom/vioxxpdf/vioxx timeline.pdf (last visited Nov. 13, 2006) (stating "APPROVewas a multi-center, randomized, placebo-controlled, double-blind study to determine theeffect of 156 weeks (3 years) of treatment with rofecoxib on the recurrence of adenomatouspolyps of the large bowel in patients with a history of colorectal adenomas.").

133 See id. (explaining "VICTOR was a randomized, double-blind, placebo-controlled,international, multicenter study of VIOXX in 7,000 colorectal cancer patients followingpotentially curative therapy.").

134 See Martin & Jones, Vioxx Lawsuit, http://www.vioxx-recall-lawsuit.coml (lastvisited Nov. 13, 2006) (stating "problems with Vioxx began before the drug was approvedfor sale in the United States.").

135 See Anna Gosline, Vioxx Heart Risks Apparent for Years, NEWSCIENTIST.COM(Nov. 5, 2004), http://www.newscientist.comlarticle/dn6627-vioxx-heart-risks-apparent-for-years.html (noting "[s]cientific evidence of increased heart attack risk associated withpopular arthritis drug Vioxx was available as early as 2000 ... although the drug wasonly withdrawn in September 2004.").

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it's difficult to see why it wasn't done by the drug company or thelicensing authorities years ago. '"136

ii. Marketing of Vioxx

Instead of heeding the warning signals and the available data,Merck and its employees aggressively marketed Vioxx to doctorsand an unsuspecting public. One memorandum, dated February9, 2001, prohibited sales representatives from initiating"discussions on a study that raised heart concerns." 137 "Anotherdocument describe[d] 'obstacle handling' to overcome physicianconcerns" about Vioxx's safety.138 Internal Merck documentsmade public by the House Committee on Government Reforminvestigating how drugs are marketed to doctors revealed thatMerck instructed its salespersons to avoid discussions withdoctors regarding the cardiovascular risks found by the VIGORstudy. 139 "Sales representatives were told instead to rely on a'Cardiovascular Card' that said Vioxx was protecting the heartrather than potentially harming it."140 To market Vioxx, Merckprepared an in-house training game for Vioxx salesrepresentatives dubbed "Dodge Ball." Sales trainees could onlymove on to the next round of the card game if they gave Merck-approved answers to doctors' questions raising Vioxx safetyconcerns, or dodged such questions altogether.141 The hearingsfound evidence of a disconnect between the science and the salespitch used by the company's field staff. Merck, for example,instructed its sales representatives to provide only certainapproved study results to doctors.142 "By contrast, those studies

136 Id. Egger suggests that many participants in Vioxx trials were at a much lowerrisk of cardiovascular events than the elderly population who generally uses arthritismedications. Given a representative profile of the population using Vioxx, he believed thedrug could increase the risk of heart attacks or stroke by up to eight times. Id.

137 See Freking, supra note 114, at Nation & World. The document was presentduring a congressional inquiry by the House Government Reform Committee in May2005.

138 Id.139 Kaufman, supra note 17, at Al (announcing Gilmartin's resignation on same day

incriminating documents were made public).140 Id.141 See Vioxx Exec Explains Ethics, "Dodge Ball" CNN.coM. (July 19, 2005),

http://www.cnn.com/2O05/LAW/07/19/vioxx.trial.ap/index.html. Nancy Santanello ofMerck's department of epidemiology nonetheless asserted that participants who dodgedall of the questions could not win the game.

142 See Freking, supra note 114, at Nation &World (stating "when doctors askedabout heart risks, the sales reps were to provide a 'cardiovascular card' with data

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that raised safety questions about drugs were consideredbackground studies. Distributing the results of a backgroundstudy was 'a clear violation of company policy'."14 3

On September 17, 2001, the FDA issued a "Warning Letter" toMerck for its concerns as to its marketing of Vioxx.144 Afterreviewing Merck's marketing activities and promotionalmaterials, it concluded that "they are false, lacking in fairbalance, or otherwise misleading in violation of the Federal Food,Drug, and Cosmetic Act."' 45 The Letter chastised Merck forengaging "in a promotional campaign for Vioxx that minimizedthe potentially serious cardiovascular findings that wereobserved" in the VIGOR study.146 Regarding Merck's explanationfor the VIGOR results that naproxen benefits the heart but thatVioxx does no harm, the FDA stated that Merck had failed "todisclose" that its "explanation is hypothetical, has not beendemonstrated by substantial evidence, and that there is anotherreasonable explanation," that Vioxx may simply increase therisks of cardiovascular events.1 47 "As you know," the FDAexplained to Gilmartin, "the reason for the difference betweenVioxx and naproxen has not been determined."1 48 The FDAidentified the following Merck press release from May 22, 2001,"Merck Confirms Favorable Cardiovascular Safety Profile ofVioxx," which the FDA concluded was also "false ormisleading."149 "Your claim in the press release," the FDA wrote,"that Vioxx has a 'favorable cardiovascular safety profile,' issimply incomprehensible, given the rate of MI and seriouscardiovascular events compared to naproxen."150 In addition, theLetter continued, "Merck sales representatives have engaged in

suggesting that Vioxx could be eight to 11 times safer than other anti-inflammatorydrugs.").

143 See Henry Waxman, The Lessons of Vioxx-Drug Safety and Sales, 352 NEW ENG.J. MED. 2576, 2577 (2004). Waxman, a Democrat, is a House representative fromCalifornia and participated in the congressional hearings on May 5, 2005, before theGovernment Reform Committee of the U.S. House.

144 See generally, FDA Warning Letter to Raymond V. Gilmartin, President and CEOMerck & Co., Inc., (Sept. 17, 2001), available at www.fda.gov/foi/warningletters/g1751d.pdf. FDA experts had publicly expressed serious concerns to the agency's advisorycommittee about its promotional and marketing activities deeming Vioxx safe.

145 Id. at 1.146 Id.147 Id. at 1-2.148 Id. at 3-4.149 Id. at 6.150 Id.

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false or misleading promotional activities that also minimize thepotentially serious MI results observed in the VIGOR trial."'51The FDA 2001 Warning Letter noted that on December 16, 1999,the FDA had objected to Merck's "dissemination of promotionalmaterials for Vioxx that misrepresented Vioxx's safety profile,contained unsubstantiated comparative claims, and lacked fairbalance," but that Merck had taken no action to remedy theseviolations.15 2

iii. Silencing Critics

In addition to aggressive and misleading marketing strategies,Merck, along with the FDA, has been accused of harassingVioxx's critics.153 In an investigation by the Senate FinanceCommittee, two leading scientists testified that they were"pressured to back off criticism of Vioxx" after expressing concernthat the drug might increase the risks of heart attacks andstrokes.154 David Graham, a scientist at FDA, said that "when heraised questions about the safety of Vioxx with other FDAofficials, he was pressured to keep quiet."' 55 He also said theFDA tried to prevent him from publishing his findings onVioxx. 156 Gurkirpal Singh, a professor at Stanford University'smedical school, said that a Merck senior executive had contactedhis superiors to warn that if Singh continued to express hisconcerns about Vioxx he would have career problems in thefuture. Singh explained, "I was warned that if I persisted in thisfashion, there would be serious consequences for me." 157 Singhtestified that "questions about Vioxx's safety were known toMerck years before its introduction, and he accused the company

151 Id. at 7.152 See id. (stating that Merck continued its behavior despite written notification of

similar violations).153 See Mondics, supra note 2, at Al.154 See id. As a result of this internal pressure, an F.D.A. scientist expressed his

opinion that as currently configured the FDA is "incapable of protecting America againstanother Vioxx." Id.

155 Id.156 FDA and Merck Vioxx Probe by House Energy and Commerce Committee, MED.

NEWS TODAY (Nov. 24, 2004), available at hftp://www.medicalnewstoday.com/printerfriendlynews.php?newsid=16822 (commenting that Graham's bosses at FDA triedto prevent him from publishing his Vioxx findings).

157 See Mondics, supra note 2, at Al.

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of designing studies that would emphasize the benefits whileminimizing the risks."158

C. Merck's Escalating Legal Problems over Vioxx

The 9,650 individual Vioxx law suits filed as of April 2006 maybe just the start of the roller coaster ride for Merck.159 In 2005,the Texas Attorney General filed suit against the company,demanding $168 million in damages for willfully misrepresentingVioxx's safety to the state, which filled an estimated 700,000subscriptions through Medicaid.160 If the punitive damage awardhanded down in New Jersey on April 11, 2006 in the McDarbycase is upheld, experts said that this could trigger a statecriminal investigation.161 In the federal sector, the JusticeDepartment has already launched a criminal investigationrelated to Merck's research, marketing, and selling of Vioxx, andthe Securities and Exchange Committee is conducting aninformal inquiry.162 The House Energy and CommerceCommittee held public hearings in November, 2004, on Merckand the FDA's handling of the drug's safety issues.163 On May 5,2005, the House Government Reform Committee conductedpublic hearings on FDA reform, focusing on Merck and Vioxx.164

In addition to governmental investigations, a class action lawsuithas been filed in federal court in New Jersey on behalf of

158 See id. (explaining Singh's statements).159 See Vioxx Plaintiff Gets $13.5 Million in Damages: Jury Finds that Merck Failed

to Warn N.J. Man of Heart Attack Risks, MSNBC.COM (Apr. 12, 2006) [hereinafter VioxxPlaintiff Gets $13.5 Million in Damages], available at http://www.msnbc.msn.com.id.12267697 (estimating number of lawsuits filed in state and federal courts againstMerck).

160 See Texas Sues Merck in Vioxx Recall Case (July 1, 2005), available athttp://www.nynippon.com/vioxx/?p=8 (commenting further that allegations against Merckinclude violating Medicaid fraud law in order to gain profits for company).

161 See Vioxx Plaintiff Gets $13.5 Million in Damages, supra note 159 (stating thatruling in McDarby could lead to investigation by state Attorney's General's Office).

162 See Canadian Shares Cautiously Climb at Open, THOMPSON FIN. CORP. GROUP(Nov. 9, 2004), available at http://www.prnewswire.comcgi-bin/stories (summarizingJustice Department's commencement of criminal investigation regarding how Merckhandled Vioxx).

163 See Letter from Joe Barton, Chairman, U.S. House of Representatives Committeeon Energy and Commerce, to Raymond Gilmartin (Nov. 23, 2004), available athttp://energycommerce.house.gov/108News/11232004_1413.htm (concerning issuesrelating to Vioxx's withdrawal from marketplace).

164 See House Government Reform Committee to Meet on FDA (May 5, 2005), availableat http://gooznews.com/archives/000121.html (looking to give FDA "safety officials morepower to pull drugs from the market and order new clinical trials.").

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participants and beneficiaries of Merck's Savings and SecurityPlan and Employee Stock Purchase and Security plan.165 Thesuit alleges that Merck breached its fiduciary duties under theEmployee Retirement Income Security Act by, among otherthings, failing to prudently manage the Plan and its assets, and"failing to provide complete and accurate information toparticipants and beneficiaries."166

Whatever profit Merck made from Vioxx will be wiped out bythe litigation. 67 As to whether that litigation is warranted, orthe result of greedy attorneys and their clients taking a shot atthe great American lottery-the jury system-it seems clear thatthe litigation against Merck is well-founded. 168 The company andits thousands of employees have hidden information and reportsfrom prescribing doctors and the public and have fraudulentlyand aggressively marketed Vioxx after studies showed, bothbefore and after FDA approval, that there was a two to five timesincrease in cardiovascular risks for those taking Vioxx over otherpainkillers or a placebo.169 Merck's insistence that theyresponded appropriately to evidence of risks and released allreliable medical data to the FDA and the public, is simply asmokescreen and rationalization to make executives and

165 See Merck & Co. ERISA Litigation, KELLER ROHRBACK LAW OFFICES, available athttp://www.erisafraud.comlDefault.aspx?tabid=1031 (last visited Nov. 13, 2006)(explaining complaint was filed in District Court of New Jersey and providing associatedcourt documents).

166 See id. (noting amended complaint was filed during class period alleging variety ofreasons for Merck's breach of their fiduciary duty).

167 See Mondics, supra note 2, at Al (highlighting that Vioxx generated sales inexcess of $2.5 billion per year since Vioxx was introduced in 1999); see also Vioxx RecallLawsuits to Exceed 100,000 (May 24, 2005), available at http://www.mynippon.com/vioxxI2005/05/vioxx-recall-lawsuits-to-exceed- 1000000.html (noting that Merck's oftencited legal liability is $18 billion, but some estimates say it could reach $55 billion).

168 See, e.g., Henry Waxman, The Marketing of Vioxx to Physicians, Memorandum toDemocratic Members of the Government Reform Committee (May 5, 2005), available athttp://www.democrats.reform.house.agov/story.asp?ID=848&Issue=Prescription+Drugs(citing a recent study that "estimated that as many as 88,000 to 140,000 Americans havesuffered Vioxx-related heart attacks, strokes, and other serious medical complications.").

169 See Kaufman, supra note 17, at A1. Merck "directed its 3,000 person Vioxx salesforce to avoid discussions with doctors" about cardiovascular risks, and coachedrepresentatives to be "aggressive salesman." Id. See also Alex Berenson, et al., DespiteWarnings, Drug Giant Took Long Path to Vioxx Recall, N.Y. TIMES (Nov. 14, 2004),[hereinafter Despite Warnings, Drug Giant Took Long Path to Vioxx Recall), available athttp://www.nytimes.com. Merck ignored countless warning signs. Even before Vioxx'sapproval, the FDA cited conceivable harm to the heart. Furthermore, in 2000, the VIGORstudy stated that those taking Vioxx were clearly at a greater cardiovascular risk thanthose taking naproxen. The FDA even sent a letter to Merck in 2001, telling them "tocorrect false or misleading impressions and information," yet the drug was not removedfrom the market until September of 2004. Id.

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employees feel better when they wake up in the morning.170 It isanalogous to the seven tobacco industry executives in the 1980'sstanding before a Congressional committee and swearing underoath that they did not believe tobacco was addictive. During theCongressional Reform Committee hearings in May 2005, oneCongressman defended Merck's marketing scheme by profferingthat there was no indication the sales tactics were illegal.171 Thefrosty response from one congressman was, "[i]sn't there a role ofethics to play here?"172

Juries will likely punish Merck severely as jurors placethemselves in the shoes of plaintiffs suffering from a heart attackor stroke who either died like Robert Ernst or are seriouslydebilitated like John McDarby or Gerald Barnett. Those lessseverely debilitated by heart attack or stroke after taking Vioxxfor only a short time, on the other hand, may have difficultypersuading a jury that Vioxx was the "cause" of theircardiovascular event. 173 But the Ernsts and McDarbys andBarnetts are likely to jump the "causation" hurdle with juries.174

In aggressively and with abandon, continuing to market Vioxxafter several studies showed an increased risk from taking Vioxx,Merck and its employees murdered people.175

D. What Makes Employees so Deadly Loyal?

The evidence is so overwhelming that it is difficult tounderstand how Merck's employees can still wholeheartedlysupport the company's actions. And yet, ten Merck employees, inthree MBA business ethics classes, at two different universities

170 See, e.g., Kaufman, supra note 17, at Al (quoting Merck's vice president sayingMerck acted "appropriately and extensively" in its studies of Vioxx, and in disclosinginformation)..

171 See Freking, supra note 114, at Nation & World, May 5, 2005 (describinglawmakers' statements).

172 Id. (quoting Representative Gil Gutknecht of Minnesota).173 See, e.g., Merck Wins Judgment in Vioxx Case, INT'L HERALD TRIB. (Sept. 27,

2006), available at http://www.iht.com/articles/2006/09/27/business/vioxx.php (reportingthat federal jury ruled in favor of Merck in lawsuit by fifty-six-year-old man who survivedheart attack after taking Vioxx for only four-and-a-half months).

174 See, e.g., $50 Million Award, supra note 58 (citing Barnett v. Merck case, wherejury awarded litigant $50 million dollars after he suffered heart attack and lost ten yearsof his life expectancy).

175 See Kaufman, supra note 17, at Al (elaborating on Merck's aggressive marketing);see also Despite Warnings, Drug Giant Took Long Path to Vioxx Recall, supra note 169(proposing FDA scientist, David Graham's estimate that Vioxx is associated with morethan 27,000 heart attacks or deaths linked to cardiac problems).

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unabashedly are incensed at the suggestion that Merck didanything unethical. They point to past examples of Merckreleasing its patent on streptomycin, giving away medications tocombat "river blindness," and providing free prescriptions for theelderly. The ten employees accept without reservationGilmartin's defense that no "credible" scientific evidence existedto show Vioxx was dangerous until the September 2004 analysisof the colon polyps study. But this is simply wishful thinking;and Merck turned a blind eye to any study that had negativeresults. In discussing how employees sublimated safety concernsand marketed Vioxx, one Merck employee in a moment of candorreflected: "Perhaps we were guilty of 'group think'."176

Employees simply accepted their boss's explanations withoutthinking, much like most MBA students accept the mantra of"maximizing profits" simply because this is what they have beentaught since their first year undergraduate business courses. Infact, one study of 2000 graduate students from the top thirteenbusiness schools found that a business school MBA education notonly fails to improve the moral character of the students, itactually weakens it as students become indoctrinated with thebelief that the prime responsibility of the corporation is tomaximize profit and shareholder value.177

Merck employees simply accepted the corporate rationale-they were good team players. "Loyalty" is a hallowed word-revered and rewarded. Employee evaluations and promotionsare based on being "loyal" and a "team player." Do what is bestfor the organization. As such, employees often bury their owninternal moral code, as well as their intellect. They go into thedeep freeze, as they often blindly follow those in authority. Ordoes that statement seem too bold? But if it is, then how can weexplain the Vioxx debacle? Why did not a single employee blowthe whistle on Merck and its marketing practices?

Perhaps it is because our whole educational system, as well asthe corporatocracy, teaches us to defer to authority. It teaches usto be followers, to be loyal, and to suspend our intellect. A study

176 The Merck employee was in the author's MBA Business Ethics class at DeSalesUniversity during the winter 2006 term.

177 Dennis A. Gioia, Business Education's Role in the Crisis of Corporate Confidence,Penn State Smeal College of Business, (Aug. 2002), available athttp://www.smeal.psu.edu/news/releases/aug02/business.html (arguing this is notinfluence we as society should want to have).

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of MBA graduates from Harvard several years after entering thebusiness world reveals the truth about corporations-they wantminions, not critical thinkers with a functioning internal moralcore. The MBA study revealed informal but powerful"commandments," which corporations communicated to thegraduates early in their careers: Among those commandments-performance is what really counts so make your numbers; beloyal and show you are a team player; and don't over invest inethical behavior. 178 The Harvard study shows the premium onbeing loyal and being a follower.

But teaching students to be drones begins not during an MBAprogram, but in childhood and continues throughout much of theeducational experience. At an early age, we are taught our placein the hierarchy. We are taught not to question authority, andwe call teachers by last names to show us that in the peckingorder they are above us and are to be respected and followed.John Gatto, a former "teacher of the year" for the City of NewYork as well as "teacher of the year" for the state of New York,has described how a public school education harms our kids andsociety. 179 His article traces the history of public schools in theUnited States. He discusses Alexander Inglis's 1918 book,Principles of Secondary Education, a book that traces thepurpose of education in this country. Inglis, for whom a lecturein education at Harvard is named, makes it clear "thatcompulsory schooling on this continent was intended to be justwhat it had been for Prussia in the 1820s, a fifth column into theburgeoning democratic movement that threatened to give thepeasants and the proletarians a voice at the bargaining table."180

Inglis breaks down the actual purpose of modern schooling intospecific functions. One function served by schools is that they"are to establish fixed habits of reaction to authority. This, ofcourse, precludes critical judgment completely."181 A secondpurpose of education is to make children as alike as possible,since people who conform are predictable, and "this is of great

178 GEORGE STEINER & JOHN STEINER, BUSINESS GOVERNMENT, AND SOCIETY 198

(McGraw-Hill 11th ed. 2005).179 John Taylor Gatto, Against School, HARPER'S MAG. (Sept. 2003), available at

http://www.spinninglobe.net/againstschool.htm. Gatto discusses that the public schoolsystem is not proficient in educating society's youth.

180 See id. at 36 (quoting Inglis).181 Id.

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use to those who wish to harness and manipulate a large laborforce."1 2 He continues. "[s]chools are meant to tag the unfit -with poor grades, remedial placement, and otherpunishments . ."183 The societal system implied by these ruleswill require an elite group of caretakers who will be taught howto manage and "control a population deliberately dumbed downand declawed in order that government might proceedunchallenged and corporations might never want for obedientlabor."184

Thus, Gatto proffers, school trains children to obey reflexively,without questioning or using critical judgment.1s5 He warns thatour schools are "drill centers for the habits and attitudes thatcorporate society demands."186 "Mandatory education serveschildren only incidentally; its real purpose is to turn them intoservants."187 The experience of the corporate world givescredence to Gatto's and Inglis's views on our educational system.Surveys, for example, have shown that the "behavior andexample of superiors is listed by managers as the most importantsingle influence on ethical or unethical behavior incompanies."' 88 Stated differently, the study shows that generallyemployees are "loyal" and "defer to authority" and in theworkplace sublimate their own internal moral code.

In the case of the Vioxx debacle, Merck's employees were goodteam players and good servants, but they lost their moralcompass. Executives and employees buried their morality inorder to sell its blockbuster drug, Vioxx. As many as 55,000people in the United States may have died as a result, while thedeath toll of the millions of people taking Vioxx throughout therest of the world is still not known. The Vioxx debacle is anexample of the evil of the "maximizing profits" mantra drummedinto and followed by business students. After a four-yearundergraduate business program and a three-year MBA

182 Id.183 Id. at 37.184 Id.185 Gatto, supra note 179 (arguing children's use of critical judgment should be one of

public school systems' main goals).186 Id. at 38.187 Id.188 GEORGE STEINER & JOHN STEINER, BUSINESS, GOVERNMENT, AND SOCIETY 185

(McGraw Hill 7th ed. 1994).

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program, most students have been brainwashed to the point thatthe mantra seems like manifest destiny. Perhaps it is time forbusiness schools and corporate America to rethink the mantra.

CONCLUSION

How did the Vioxx debacle happen in a company that hasalways appeared to have such high ethical standards? Theanswer perhaps lies in the first paragraph of this article.Between 1999-01 Merck lost its patent protection on five of itsbest-selling drugs; two other drugs were to lose their patentprotection by 2007, and Merck had not had a blockbuster drug foryears. Merck was feeling the stress of losing market share andprofits. Merck was under pressure to maximize its profits in acompany whose profits had flattened. And yet the issue was lifeand death. During the Ernst trial, one of the Merck witnesses,Dr. Santanello, grew irritated as Mark Lanier asked her whetherMr. Ernst had risk factors for heart attacks beyond the use ofVioxx. 'You're playing this game," she said.18 9 "This is not agame," he responded. "My client's dead."19o

189 In Training Video, Merck Said Vioxx Did Not Increase Risk of Heart Attack, supranote 121, at C4.

190 Id.

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